Clinical Trials Logo
  1. Home
  2. Venous Malformation
  3. NCT04930952
  4. Details
NCT04930952 Clinical Trial

Complications of Ethanol-amine Oleate Intralesional Sclerotherapy

Venous Malformation Clinical Trial

Official title:
Complications of Ethanol-amine Oleate Intralesional Sclerotherapy Injections of Maxillofacial Venous Malformations in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04930952
Other study ID # 157-2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 28, 2019
Est. completion date March 3, 2021

Study information
Verified date June 2021
Source Suez Canal University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations in pediatric patients

Description:

Maxillofacial Venous malformations cause many functional and esthetic complications in children, intralesional sclerotherapy is the best choice of treatment; and Ethanol-amine Oleate has been the most commonly used sclerosing agent. The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date March 3, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers
Gender All
Age group N/A to 12 Years
Eligibility Inclusion Criteria: maxillofacial venous malformation - Exclusion Criteria: 1. Patients with lung, liver, or kidney diseases 2. Patients with Klippel-Trenaunay syndrome 3. Patients mental or physical disabilities

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ethanol-amine Oleate Sclerotherapy Injection
Intralesional Sclerotherapy Injection

Locations
Country Name City State
Egypt Suez Canal University Ismailia

Sponsors (1)
Lead Sponsor Collaborator
Suez Canal University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Response Complete Response - Marked Improvement - Moderate Improvement - No Response 12 months
See also
  Status Clinical Trial Phase
Terminated NCT04409145 - First in Human Trial of Topical VT30 in Pts With Venous/Lymphatic Malformations Assoc With PIK3CA or TEK Gene Mutations Phase 1/Phase 2
Completed NCT05586919 - Treatment of Venous Malformation N/A
Completed NCT04637997 - Influence of Flat-knitted Compression Stockings Class I and II on Venous Malformations N/A
Recruiting NCT03767660 - Efficacy of Rapamycin (Sirolimus) in the Treatment of BRBNS, Hereditary or Sporadic Venous Malformation Phase 4
Completed NCT04486599 - Electromagnetic Navigation During Ultrasound Guided Foam Sclerotherapy for Venous Malformations N/A
Recruiting NCT04861064 - Weekly Sirolimus Therapy Phase 2
Recruiting NCT05563831 - National Evaluation of Patients With PIK3CA-Related Overgrowth Spectrum (PROS)
Recruiting NCT04258046 - Trametinib in the Treatment of Complicated Extracranial Arterial Venous Malformation Phase 2
Not yet recruiting NCT05983159 - A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations Phase 2
Active, not recruiting NCT01347294 - Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations Phase 4
Completed NCT04836884 - Vascular Anomaly Pathology and Genomics Biopsy Study N/A